e-Pharmatimes

Quality assurance is defined as a wide ranging concept, which covers matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the objective of ensuring that the pharmaceutical products are of the quality required for their intended use. Quality Assurance is the heart and soul of Quality Control. Quality Assurance = Quality Control +Good Manufacturing  Practice The System of Quality Assurance: Pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practices (GLP) and good clinical practices (GCP). Product and control operations are clearly specified in a written form and GMP requirements are adopted. Managerial responsibilities are clearly specified in the job description. Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials. All nec...